Amplatzer™ 9-PDA2-06-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00811806011264), received between Aug 6, 2020 and Sep 28, 2026 — classified as 9 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926391 ↗
• MalfunctionFeb 10, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310285 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 06-06MM AMPLATZER ADO II OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING , THE DEVICE DID NOT CONFORM TO ITS DESIRED SHAPE, IT WAS RETRACTED BACKED INTO THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THEREFORE, THE PATIENT WAS REFERRED FOR CARDIAC SURGERY FOR OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708816 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 06-06MM AMPLATZER ADO II OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTED THAT THE DEVICE DID NOT HOLD IT SHAPE AFTER OPENING AND DEFORMED, THEREFORE THE DEFORMED DEVICE WAS RETRACTED BACK INTO THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT WAS REFERRED FOR CARDIAC SURGERY FOR OPERATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708815 ↗
• MalfunctionNov 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637142 ↗
• InjuryAug 27, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 5F TORQVUE DELIVERY SYSTEM. THE DIMENSIONS OF THE DEFECT WERE 5MM DIAMETER AND 6MM LENGTH. SIZING WAS DETERMINED VIA ULTRASOUND. DURING IMPLANT, THE OCCLUDER WAS "POORLY FORMED DURING THE OPERATION AND LATER FELL OFF AND WAS REMOVED." THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS RELEASED FROM THE DELIVERY CABLE, HOWEVER "MOLDING WAS NOT GOOD AFTER NORMAL RELEASE, AND IT FALLS OFF." THE PATIENT'S DEFECT WAS SURGICALLY REPAIRED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906763 ↗
• InjuryDec 11, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE OCCLUDER "COULD NOT HOLD THE HEART TISSUE IN PLACE, RESULTING IN A SMALL AMOUNT OF ACCUMULATION." THE USER FURTHER DESCRIBED THAT THE PROCEDURE FAILED DUE TO THE PATIENT'S HEART TISSUE PROBLEMS, WHICH RESULTED IN THE OCCLUDER NOT BEING ABLE TO HOLD THE HEART TISSUE. THEREFORE, THE PROCEDURE WAS STOPPED AND NO DEVICE WAS ULTIMATELY IMPLANTED DUE TO PATIENT ANATOMY. THERE ARE NO ALLEGATIONS OF MALFUNCTION WITH THE 6MM DUCT OCCLUDER AND NO ALLEGATIONS TO THE SIZING OF THE OCCLUDER. OF NOTE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 20908319 ↗
• InjuryDec 4, 2024Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MM/4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN ABBOTT DELIVERY SYSTEM TO TREAT A 3-4MM MITRAL VALVE LEAFLET PERFORATION. WHEN PLACED, A SMALL RESIDUAL SHUNT WAS NOTED SO THE OCCLUDER WAS REMOVED AND REPLACED WITH A 6MM/6MM AMPLATZER DUCT OCCLUDER UTILIZING THE SAME DELIVERY SYSTEM. DEVICE WAS PLACED SUCCESSFULLY AND WITH NO SHUNT. STABILITY TEST PERFORMED. ON AN UNKNOWN DATE, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED AND THE DEVICE HAD COMPLETELY DISLODGED. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS DUE TO THE DISLODGEMENT, AND NO BLOCKAGE OF BLOOD FLOW. DEVICE WAS RETRIEVED PERCUTANEOUSLY.

  Patient problems: Embolism/Embolus

  MAUDE report 20845844 ↗
• MalfunctionJul 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT USING A 5F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE DEPLOYED AS A COBRA DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPLACEMENT DEVICE USED. THE DEFECT WAS CLOSED BY SURGICAL PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732125 ↗
• InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿PERCUTANEOUS CLOSURE OF SEVERE CALCIFIED PATENT DUCTUS ARTERIOSUS WITH TWO AMPLATZER DEVICES¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 89-YEAR-OLD WOMAN WITH PATENT DUCTUS ARTERIOSUS (PDA) WITH SEVERE CALCIFICATION. IT WAS REPORTED ON AN UNKNOWN DATE THAT A 6-6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT TO OCCLUDE A PATIENT¿S PDA THAT MEASURED 6MM IN DIAMETER AND 14MM FOR DUCTUS LENGTH. AFTER THE 6-6MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED, IT WAS SEEN VIA ANGIOGRAPHY THERE WAS A RESIDUAL SHUNT THROUGH THE PDA. THE PHYSICIAN RELEASED THE OCCLUDER HOPING THE RESIDUAL SHUNT WOULD DISAPPEAR DUE TO ENDOTHELIALIZATION. IT WAS LATER REPORTED A FEW MONTHS LATER ON AN UNKNOWN DATE, FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED NO IMPROVEMENT IN THE RESIDUAL SHUNT AND THE PATIENT SYMPTOMS WORSENED. A DECISION WAS MADE TO IMPLANT A 14-10MM AMPLATZER VASCULAR PLUG II. AFTER A SUCCESSFUL IMPLANT, IT WAS NOTED THE RESIDUAL SHUNT HAD DISAPPEARED. THE ARTICLE CONCLUDED THAT PDA IN ELDERLY INDIVIDUALS COMMONLY FEATURES SEVERE CALCIFICATION. HOWEVER, SEVERE CALCIFICATION CAN PREVENT ENDOTHELIALIZATION DUE TO LACK OF APPROPRIATE DEPLOYMENT. AN ADDITION

  Patient problems: Insufficient Information

  MAUDE report 17499509 ↗
• InjuryJan 16, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR AN IMPLANT. THE DIMENSIONS OF THE DEFECT WAS 5-6MM AND WAS DETERMINE BY FLUOROSCOPIC. DURING PROCEDURE, THE DEVICE WAS SUCCESSFULLY IMPLANTED. DURING THE ANGIO CHECK, IT WAS NOTICED THAT THE DEVICE HAD EMBOLIZED IN THE RIGHT VENTRICLE AND AN EMERGENCY PROCEDURE WAS DONE TO RETRIEVED THE DEVICE SURGICALLY FROM THE PATIENT. NO DEVICE WAS IMPLANTED. PER THE PHYSICIAN, IT WAS DEPLOYMENT TECHNIQUE THAT CAUSED THE DEVICE TO EMBOLIZED. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16178830 ↗
• MalfunctionAug 26, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6MMBY 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANTATION USING A 6F NON-ABBOTT GUIDING SHEATH. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS NOT TAKING THE CORRECT SHAPE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT. THERE WAS NO REPLACEMENT DEVICE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES, AND NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306562 ↗
• MalfunctionMay 26, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6/6MM AMPLATZER DUCT OCCLUDER II DEVICE WAS SELECTED FOR IMPLANT USING A NON ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING DESIRED SHAPE, WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. IT IS UNKNOWN IF THERE WAS A DEVICE IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517720 ↗
• MalfunctionApr 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT ON (B)(6) 2022. A NON-ABBOTT DELIVERY SYSTEM WAS USED. DURING AN ATTEMPT TO DEPLOY THE DEVICE AND THE DEVICE PRESENTED WITH A COBRA DEFORMATION. THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY SYSTEM. A NEW, 5/6 AMPLATZER DUCT OCCLUDER WAS IMPLANTED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, RECOVERED AND HAS BEEN DISCHARGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191582 ↗
• InjuryJan 7, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2021, A 6/6MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED. SEVERAL MINUTES AFTER DEVICE WAS RELEASED IT EMBOLIZED INTO THE LEFT PULMONARY ARTERY. THE PATIENT WAS TRANSFERRED TO SURGERY AND THE OCCULDER WAS REMOVED AND A NEW DEVICE WAS NOT IMPLANTED AND THE DEFECT WAS CLOSED BY SURGEON. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190769 ↗
• InjuryDec 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 6/6 AMPLATZER DUCT OCCLUDER II WAS SELECTED BASED ON MEASUREMENTS OF THE DUCTAL ANATOMY FOR IMPLANT IN THE PATIENT. DURING THE PROCEDURE THE DEVICE WAS POSITIONED, RELEASED FROM THE DELIVERY CABLE AND THEN EMBOLIZED INTO THE PATIENT'S PULMONARY TRUNK. THE DEVICE WAS RETRIEVED USING A MERIT MEDICAL SNARE. THE PATIENT DID NOT EXPERIENCE ANY SERIOUS INJURIES AND A 6MM AMPLATZER DUCT OCCLUDER(ADO) WAS USED IN REPLACEMENT SINCE THE DUCTUS WAS TOO LAX. THE ADO DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Embolism; Foreign Body Embolism

  MAUDE report 10924745 ↗
• InjuryOct 30, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020, A 6X6MM AMPLATZER DUCT OCCLUDER II (ADOII) WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, PRIOR TO THE DEPLOY OF THE ADOII, THE NON-ABBOTT SHEATH GOT CAUGHT BETWEEN TWO MITRACLIPS THAT WERE IMPLANTED APPROXIMATELY 2 MONTHS AGO. THE OCCLUDER WAS INTENDED FOR IMPLANT BETWEEN THE 2 CLIPS; FURTHER DESCRIBED AS A2P2. THE NON-ABBOTT SHEATH WAS CUT AT THE GROIN AND THE SHEATH AND OCCLUDER REMAIN IN THE ANATOMY OF THE PATIENT, STILL CAUGHT WITHIN THE CLIPS. THE PHYSICIAN REPORTS NO PLANS TO REMOVE EITHER PRODUCTS. A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE DELAY WAS REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10763773 ↗
• InjuryAug 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020 A 6/4 AMPLATZER DUCT OCCLUDER II (LOT#6736010) WAS SELECTED FOR IMPLANT IN A (B)(6) YEAR OLD MALE. DURING THE PROCEDURE THE DEVICE WAS DETERMINED TO BE TOO SMALL AND WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A 6/6 AMPLATZER DUCT OCCLUDER II (LOT#7481147). THE 6/6 AMPLATZER DUCT OCCLUDER II WAS RELEASED FROM THE DELIVERY CABLE AND SECONDS LATER THE DEVICE EMBOLIZED INTO THE PATIENT'S VENTRICULAR OUTFLOW TRACK. ACCORDING TO THE PHYSICIAN THIS DID NOT CAUSE ANY PATIENT ISSUES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE FOLLOWING MONDAY, THE PATIENT UNDERWENT ELECTIVE MITRAL VALVE SURGERY. THE EMBOLIZED DEVICE WAS REMOVED AND THE DEFECT WAS SURGICALLY CLOSED. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Embolus

  MAUDE report 10376157 ↗